Rationale and design for the Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE) trial.
BACKGROUND: Cardiac magnetic resonance imaging (CMR) can accurately determine infarct size. Prior studies using indirect methods and CMR to assess infarct size have shown that patients with larger myocardial infarctions have worse prognoses. Implantable cardioverter defibrillators (ICD) have been shown to improve survival among patients with severe left ventricular (LV) dysfunction. However, the majority of cardiac arrests occur in patients with higher ejection fractions. METHODS: The Defibrillators To Reduce Risk By Magnetic Resonance Imaging Evaluation study (DETERMINE) is a prospective, multicenter, randomized, clinical trial in patients with coronary artery disease (CAD) and mild-to-moderate LV dysfunction. The purpose of this trial is to test the hypothesis that patients with an infarct size > or = 10% of LV mass, randomized to ICD plus appropriate medical therapy will have improved survival compared with patients randomized to medical therapy alone. Cine and myocardial delayed contrast CMR will be performed in patients with CAD. The primary endpoint will be death from any cause. At least 10,000 patients with CAD will undergo CMR. The target enrollment is 1,550 patients with an estimated 36-month enrollment period. The patients will be followed up for 24 months after the last patient randomization. During the follow-up period, 330 deaths are estimated to occur. This study is powered to detect a 28% reduction in mortality by ICD therapy. CONCLUSION: The DETERMINE trial will assess the efficacy of ICD therapy to improve survival among patients with CAD, mild-to-moderate LV dysfunction, and infarct size > or = 10% of LV mass as measured by CMR.
Kadish, AH; Bello, D; Finn, JP; Bonow, RO; Schaechter, A; Subacius, H; Albert, C; Daubert, JP; Fonseca, CG; Goldberger, JJ
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